Trixeo is the first and only triple-combination therapy approved in the EU for patients 12 years and older, independent of exacerbation history

The European Union (EU) has approved AstraZeneca’s Trixeo Aerosphere as a daily maintenance therapy for asthma patients aged 12 and older. The single-inhaler, fixed-dose triple combination consists of budesonide, glycopyrronium, and formoterol fumarate dihydrate (BGF). This regulatory clearance specifically covers individuals whose asthma remains poorly managed despite using a standard dual-therapy regimen of a medium-dose inhaled corticosteroid (ICS) combined with a long-acting beta2-agonist (LABA).

By merging the traditional ICS/LABA dual action with a long-acting muscarinic antagonist (LAMA), Trixeo Aerosphere simplifies advanced treatment into a unified device. While known as Trixeo Aerosphere within the EU, the exact same three-drug combination is commercially available under the brand name Breztri Aerosphere in the United States, Japan, and China.

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and was based on the positive results from the KALOS and LOGOS Phase III trials. In the trials, Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators.

In the pooled analysis of KALOS and LOGOS, Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients including those with no asthma exacerbations in the previous year.

Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Every day, I see patients whose asthma remains uncontrolled despite maintenance treatment, leaving them with persistent symptoms like difficulty breathing and declining lung function and at risk of exacerbations, which can have serious health consequences. The approval of Trixeo in Europe as the first triple-combination therapy in a single inhaler for patients 12 years of age and older provides an important new treatment option that has been shown to improve asthma control and reduce future risk of exacerbations, regardless of exacerbation history.”

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Today’s approval in asthma builds on Trixeo’s established role in improving outcomes in patients with COPD. This means we can now bring the benefits of a single-inhaler triple-combination therapy to people aged 12 years and older in Europe whose asthma remains uncontrolled on dual inhaled therapy.”

Trixeo demonstrated a rapid onset of action, significantly improving lung function within five minutes of the first dose in a key secondary endpoint. As a maintenance therapy, Trixeo is not intended to relieve sudden breathing problems and does not replace a rescue inhaler. Results from the KALOS and LOGOS trials, published in The Lancet Respiratory Medicine in February 2026, identified no new safety or tolerability signals.

Trixeo/Breztri, is also approved in the US and Japan for treatment of asthma and is currently under review in China, as well as other countries. Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan.